Federal Register / Vol. 77, No. 226 / Friday, November 23, 2012 / Notices 70163 

1 Delegated to CCIIO, 76 FR 53903 through 53906 

2011–08–30. 

30269, Officer: Joshua Wolf, Member/ 

Manager (QI), Application Type: New 

NVO & OFF License. 

Pegasus Logistics Group, Inc. (NVO & 

OFF), 615 Freeport Pkwy, Suite 100, 

Coppell, TX 75019, Officer: Kenneth 

C. Beam, President (QI), Application 

Type: Add NVO Service. 

Reliable Shipping Agency, LLC (NVO), 

7710 Brooklyn Boulevard North, Suite 

211, Brooklyn Park, MN 55443, 

Officers: Wells Wescott, Manager (QI), 

Christian K. Kolleh, Chief Executive 

Manager, Application Type: New 

NVO License. 

Santa Fe Group Americas, Inc. (NVO & 

OFF), 1001 S. Dairy Ashford Street, 

Suite 100, Houston, TX 77077, 

Officers: Francesca A. Vollaro, Vice 

President (QI), Lars L. Iversen, 

President, Application Type: New 

NVO & OFF License. 

SH Transport, Inc. (NVO), 1975 Charles 

Willard Street, Rancho Dominguez, 

CA 90220, Officer: Steven Park, 

President (QI), Application Type: 

New NVO License. 

Transport Partner (USA), Inc. (NVO & 

OFF), 2006 Cherry Hill Lane, 

Charleston, SC 29405, Officers: Adam 

Adaway, Secretary (QI), Wim 

Spinhoven, President, Application 

Type: Add NVO Service. 

Transports P. Fatton Inc. dba Fatton 

USA (NVO), 145 Hook Creek Blvd., 

Bldg. A5, Valley Stream, NY 11581, 

Officers: Renaud Mellier, Treasurer 

(QI), Henri Ducasse, CEO, Application 

Type: QI Change. 

Dated: November 16, 2012. 

By the Commission. 

Karen V. Gregory, 

Secretary. 

[FR Doc. 2012–28475 Filed 11–21–12; 8:45 am] 

BILLING CODE 6730–01–P 

FEDERAL MARITIME COMMISSION 

Ocean Transportation Intermediary 

License Revocations 

The Commission gives notice that the 

following Ocean Transportation 

Intermediary license has been revoked 

pursuant to section 19 of the Shipping 

Act of 1984 (46 U.S.C. 40101) effective 

on the date shown. 

License No.: 022069N. 

Name: Unique Logistics International 

(ATL) LLC. 

Address: 510 Plaza Drive, Suite 2290, 

Atlanta, GA 30349. 

Date Revoked: October 15, 2012. 

Reason: Failed to maintain a valid 

bond. 

Vern W. Hill, 

Director, Bureau of Certification and 

Licensing. 

[FR Doc. 2012–28476 Filed 11–21–12; 8:45 am] 

BILLING CODE 6730–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[CMS–9961–N] 

Recognition of Entities for the 

Accreditation of Qualified Health Plans 

AGENCY: Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: This notice announces the 

recognition of the National Committee 

for Quality Assurance (NCQA) and 

URAC as recognized accrediting entities 

for the purposes of fulfilling the 

accreditation requirement as part of 

qualified health plan certification. 

DATES: This notice is effective on 

November 20, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Rebecca Zimmermann, (301) 492–4396. 

Deborah Greene, (301) 492–4293. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 1311(c)(1)(D) of the 

Affordable Care Act specifies that to be 

certified as a qualified health plan 

(QHP) and operate in the Exchange, a 

health plan must be accredited by a 

recognized accrediting entity on a 

uniform timeline established by the 

applicable Exchange. On July 20, 2012, 

we published a final rule in the Federal 

Register (77 FR 42658) titled, ‘‘Patient 

Protection and Affordable Care Act; 

Data Collection To Support Standards 

Related to Essential Health Benefits; 

Recognition of Entities for the 

Accreditation of Qualified Health 

Plans.’’ In that rule, we finalized 45 CFR 

156.275(c), which specified the 

requirements for accrediting entities to 

be recognized for the purposes of 

fulfilling the accreditation requirement 

as part of QHP certification. We also 

established that, effective upon 

completion of the conditions at 

§ 156.275 in paragraphs (c)(2) through 

(c)(4), that the National Committee for 

Quality Assurance (NCQA) and URAC 

will be recognized as accrediting 

entities for the purposes of QHP 

certification and that the Department of 

Health and Human Services (HHS) will 

notify the public of this recognition in 

the Federal Register. As discussed in 

the preamble to the final rule published 

on July 20, 2012, the recognition of 

accrediting entities in phase one is 

effective until it is rescinded or this 

interim phase one process is replaced by 

the phase two process. 

II. Provisions of the Final Notice 

NCQA and URAC met the 

requirements and criteria described in 

the final rule to be recognized as an 

accrediting entity (77 FR 42662 through 

42668). Therefore, this notice serves as 

public notification that NCQA and 

URAC are recognized by the Secretary of 

HHS 1 as accrediting entities for the 

purposes of QHP certification. 

III. Collection of Information 

Requirements 

This document does not impose 

information collection and 

recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995. 

Dated: November 8, 2012. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2012–28440 Filed 11–20–12; 11:15 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1437–N] 

Medicare Program; Town Hall Meeting 

on FY 2014 Applications for New 

Medical Services and Technology AddOn Payments 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice of meeting. 

SUMMARY: This notice announces a 

Town Hall meeting in accordance with 

section 1886(d)(5)(K)(viii) of the Social 

Security Act (the Act) to discuss fiscal 

year (FY) 2014 applications for add-on 

payments for new medical services and 

technologies under the hospital 

inpatient prospective payment system 

(IPPS). Interested parties are invited to 

this meeting to present their comments, 

recommendations, and data regarding 

whether the FY 2014 new medical 

services and technologies applications 

meet the substantial clinical 

improvement criterion. 

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70164 Federal Register / Vol. 77, No. 226 / Friday, November 23, 2012 / Notices 

DATES: Meeting Date: The Town Hall 

Meeting announced in this notice will 

be held on Tuesday, February 5, 2013. 

The Town Hall Meeting will begin at 

9:00 a.m. Eastern Standard Time (e.s.t.) 

and check-in will begin at 8:30 a.m. 

e.s.t. Only one check-in is required to 

enter the building. 

Deadline for Registration for 

Participants (not Presenting) at the 

Town Hall Meeting and Submitting 

Requests for Special Accommodations: 

The deadline to register to attend the 

Town Hall Meeting and requests for 

special accommodations must be 

received no later than 5:00 p.m., e.s.t. on 

Monday, January 21, 2013. 

Deadline for Registration of Presenters 

of the Town Hall Meeting: The deadline 

to register to present at the Town Hall 

Meeting must be received no later than 

5:00 p.m., e.s.t. on Monday, January 14, 

2013. 

Deadline for Submission of Agenda 

Item(s) or Written Comments for the 

Town Hall Meeting: Written comments 

and agenda items for discussion at the 

Town Hall Meeting, including agenda 

items by presenters, must be received by 

Monday, January 14, 2013. In addition 

to materials submitted for discussion at 

the Town Hall Meeting, individuals may 

submit other written comments after the 

Town Hall Meeting, as specified in the 

ADDRESSES section of this notice, on 

whether the service or technology 

represents a substantial clinical 

improvement. These comments must be 

received by Tuesday, February 26, 2013, 

for consideration in the FY 2014 IPPS 

proposed rule. 

ADDRESSES: Meeting Location: The 

Town Hall Meeting will be held in the 

main Auditorium in the central building 

of the Centers for Medicare and 

Medicaid Services located at 7500 

Security Boulevard, Baltimore, MD 

21244–1850. 

In addition, we are providing two 

alternatives to attending the meeting in 

person—(1) there will be an open tollfree phone line to call into the Town 

Hall Meeting; or (2) participants may 

view and participate in the Town Hall 

Meeting via live stream technology and/ 

or webinar. Information on these 

options are discussed in section II.B. of 

this notice. 

Registration and Special 

Accommodations: Individuals wishing 

to participate in the meeting must 

register by following the on-line 

registration instructions located in 

section III. of this notice or by 

contacting staff listed in the FOR

FURTHER INFORMATION CONTACT section of 

this notice. Individuals who need 

special accommodations should contact 

staff listed in the FOR FURTHER

INFORMATION CONTACT section of this 

notice. 

Submission of Agenda Item(s) or 

Written Comments for the Town Hall 

Meeting: Each presenter must submit an 

agenda item(s) regarding whether a FY 

2014 application meets the substantial 

clinical improvement criterion. Agenda 

items, written comments, questions or 

other statements must not exceed three 

single-spaced typed pages and may be 

sent via email to newtech@cms.hhs.gov. 

FOR FURTHER INFORMATION CONTACT: 

Michael Treitel, (410) 786–4552, 

michael.treitel@cms.hhs.gov, or Celeste 

Beauregard, (410) 786–8102, 

celeste.beauregard@cms.hhs.gov. 

Alternatively, you may forward your 

requests via email to 

newtech@cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background on the Add-On Payments 

for New Medical Services and 

Technologies Under the IPPS 

Sections 1886(d)(5)(K) and (L) of the 

Social Security Act (the Act) require the 

Secretary to establish a process of 

identifying and ensuring adequate 

payments to acute care hospitals for 

new medical services and technologies 

under Medicare. Effective for discharges 

beginning on or after October 1, 2001, 

section 1886(d)(5)(K)(i) of the Act 

requires the Secretary to establish (after 

notice and opportunity for public 

comment) a mechanism to recognize the 

costs of new services and technologies 

under the hospital inpatient prospective 

payment system (IPPS). In addition, 

section 1886(d)(5)(K)(vi) of the Act 

specifies that a medical service or 

technology will be considered ‘‘new’’ if 

it meets criteria established by the 

Secretary (after notice and opportunity 

for public comment). (See the FY 2002 

IPPS proposed rule (66 FR 22693, May 

4, 2001) and final rule (66 FR 46912, 

September 7, 2001) for a more detailed 

discussion.) 

In the September 7, 2001 final rule (66 

FR 46914), we noted that we evaluated 

a request for special payment for a new 

medical service or technology against 

the following criteria in order to 

determine if the new technology meets 

the substantial clinical improvement 

requirement: 

• The device offers a treatment option 

for a patient population unresponsive 

to, or ineligible for, currently available 

treatments. 

• The device offers the ability to 

diagnose a medical condition in a 

patient population where that medical 

condition is currently undetectable or 

offers the ability to diagnose a medical 

condition earlier in a patient population 

than allowed by currently available 

methods. There must also be evidence 

that use of the device to make a 

diagnosis affects the management of the 

patient. 

• Use of the device significantly 

improves clinical outcomes for a patient 

population as compared to currently 

available treatments. Some examples of 

outcomes that are frequently evaluated 

in studies of medical devices are the 

following: 

++ Reduced mortality rate with use of 

the device. 

++ Reduced rate of device-related 

complications. 

++ Decreased rate of subsequent 

diagnostic or therapeutic interventions 

(for example, due to reduced rate of 

recurrence of the disease process). 

++ Decreased number of future 

hospitalizations or physician visits. 

++ More rapid beneficial resolution 

of the disease process treatment because 

of the use of the device. 

++ Decreased pain, bleeding or other 

quantifiable symptoms. 

++ Reduced recovery time. 

In addition, we indicated that the 

requester is required to submit evidence 

that the technology meets one or more 

of these criteria. 

Section 503 of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (MMA) 

amended section 1886(d)(5)(K)(viii) of 

the Act to revise the process for 

evaluating new medical services and 

technology applications by requiring the 

Secretary to do the following: 

• Provide for public input regarding 

whether a new service or technology 

represents an advance in medical 

technology that substantially improves 

the diagnosis or treatment of Medicare 

beneficiaries before publication of a 

proposed rule. 

• Make public and periodically 

update a list of all the services and 

technologies for which an application is 

pending. 

• Accept comments, 

recommendations, and data from the 

public regarding whether the service or 

technology represents a substantial 

improvement. 

• Provide for a meeting at which 

organizations representing hospitals, 

physicians, manufacturers and any 

other interested party may present 

comments, recommendations, and data 

to the clinical staff of CMS as to whether 

the service or technology represents a 

substantial improvement before 

publication of a proposed rule. 

The opinions and alternatives 

provided during this meeting will assist 

us as we evaluate the new medical 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 77, No. 226 / Friday, November 23, 2012 / Notices 70165 

services and technology applications for 

fiscal year (FY) 2014. In addition, they 

will help us to evaluate our policy on 

the IPPS new technology add-on 

payment process before the publication 

of the FY 2014 IPPS proposed rule. 

II. Town Hall Meeting and Conference 

Calling/Live Streaming Information 

A. Format of the Town Hall Meeting 

As noted in section I. of this notice, 

we are required to provide for a meeting 

at which organizations representing 

hospitals, physicians, manufacturers 

and any other interested party may 

present comments, recommendations, 

and data to the clinical staff of CMS 

concerning whether the service or 

technology represents a substantial 

clinical improvement. This meeting will 

allow for a discussion of the substantial 

clinical improvement criteria on each of 

the FY 2014 new medical services and 

technology add-on payment 

applications. Information regarding the 

applications can be found on our Web 

site at http://www.cms.gov/Medicare/

Medicare-Fee-for-Service-Payment/

AcuteInpatientPPS/newtech.html. 

The majority of the meeting will be 

reserved for presentations of comments, 

recommendations, and data from 

registered presenters. The time for each 

presenter’s comments will be 

approximately 10 to 15 minutes and 

will be based on the number of 

registered presenters. Presenters will be 

scheduled to speak in the order in 

which they register and grouped by new 

technology applicant. Therefore, 

individuals who would like to present 

must register and submit their agenda 

item(s) via email to 

newtech@cms.hhs.gov by the date 

specified in the DATES section of this 

notice. 

In addition, written comments will 

also be accepted and presented at the 

meeting if they are received via email to 

newtech@cms.hhs.gov by the date 

specified in the DATES section of this 

notice. Written comments may also be 

submitted after the meeting for our 

consideration. If the comments are to be 

considered before the publication of the 

proposed rule, the comments must be 

received via email to 

newtech@cms.hhs.gov by the date 

specified in the DATES section of this 

notice. 

B. Conference Call, Live Streaming, and 

Webinar Information 

For participants who cannot attend 

the Town Hall Meeting in person, an 

open toll-free phone line, (877) 267– 

1577, has been made available. The 

conference code is ‘‘7702.’’ 

Also, there will be an option to view 

and participate in the Town Hall 

Meeting via live streaming technology 

and/or a webinar. Information on the 

option to participate via live streaming 

technology and/or a webinar will be 

provided through an upcoming listserv 

notice and posted on the New 

Technology Web site at http://www.cms.

gov/Medicare/Medicare-Fee-for-ServicePayment/AcuteInpatientPPS/

newtech.html. Continue to check the 

Web site for updates. 

Disclaimer: Because this is the first 

year that we are providing an option for 

live streaming technology and/or a 

webinar, we cannot guarantee the 

reliability of these technologies. 

III. Registration Instructions 

The Division of Acute Care in CMS is 

coordinating the meeting registration for 

the Town Hall Meeting on substantial 

clinical improvement. While there is no 

registration fee, individuals planning to 

attend the Town Hall Meeting in person 

must register to attend. 

Registration may be completed online at the following web address: 

http://www.cms.gov/Medicare/

Medicare-Fee-for-Service-Payment/

AcuteInpatientPPS/newtech.html. 

Select the link at the bottom of the page 

‘‘Register to Attend the New Technology 

Town Hall Meeting’’. After completing 

the registration, on-line registrants 

should print the confirmation page(s) 

and bring it with them to the meeting(s). 

If you are unable to register on-line, 

you may register by sending an email to 

newtech@cms.hhs.gov. Please include 

your name, address, telephone number, 

email address and fax number. If seating 

capacity has been reached, you will be 

notified that the meeting has reached 

capacity. 

IV. Security, Building, and Parking 

Guidelines 

Because these meetings will be 

located on Federal property, for security 

reasons, any persons wishing to attend 

these meetings must register by the date 

specified in the DATES section of this 

notice. Please allow sufficient time to go 

through the security checkpoints. It is 

suggested that you arrive at 7500 

Security Boulevard no later than 8:30 

a.m. e.s.t. if you are attending the Town 

Hall Meeting so that you will be able to 

arrive promptly for the meeting. 

Security measures include the 

following: 

• Presentation of government-issued 

photographic identification to the 

Federal Protective Service or Guard 

Service personnel. 

• Interior and exterior inspection of 

vehicles (this includes engine and trunk 

inspection) at the entrance to the 

grounds. Parking permits and 

instructions will be issued after the 

vehicle inspection. 

• Passing through a metal detector 

and inspection of items brought into the 

building. We note that all items brought 

to CMS, whether personal or for the 

purpose of demonstration or to support 

a demonstration, are subject to 

inspection. We cannot assume 

responsibility for coordinating the 

receipt, transfer, transport, storage, setup, safety, or timely arrival of any 

personal belongings or items used for 

demonstration or to support a 

demonstration. 

Note: Individuals who are not registered in 

advance will not be permitted to enter the 

building and will be unable to attend the 

meeting in person. The public may not enter 

the building earlier than 45 minutes prior to 

the convening of the meeting(s). 

All visitors must be escorted in areas 

other than the lower and first floor 

levels in the Central Building. Seating 

capacity is limited to the first 250 

registrants. 

Authority: Section 503 of Public Law 108– 

173. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: November 14, 2012. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2012–28478 Filed 11–21–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects 

Title: Form CB–496: Title IV–E 

Programs Quarterly Financial Report. 

OMB No.: 0970–0205. 

Description: This is a financial report 

submitted following the end of each 

fiscal quarter by each State or Tribe with 

an approved title IV–E plan 

administering any of three title IV–E 

entitlement grant programs—Foster 

Care, Adoption Assistance or 

Guardianship Assistance. 

The purpose of this form is to enable 

each State or Tribe to meet its statutory 

and regulatory requirement to report 

program expenditures made in the 

mstockstill on DSK4VPTVN1PROD with NOTICES